Monthly Member Gift September 2011

Make the Most of Your Membership!

Welcome to your free monthly gift from ISPE! Don't let a single ISPE Membership benefit go to waste - enjoy these FREE knowledge, community, and professional resources, available only to ISPE Members!

FREE Electronic Document for Members

The 2015 deadline that China's State Food and Drug Administration (SFDA) has placed on existing pharmaceutical manufacturers for implementing the SFDA’s revised GMP Guidelines is looming. Many companies in English-speaking countries are faced with the challenge of interpreting the new Guidelines and making the necessary changes at their China facilities within the next four years. If you or your company is currently involved in this process, then this month's gift will be of great interest to you.

While there is no "official" English translation of the SFDA's Guideline revision, ISPE, working with Members and staff in China, has created and vetted our own version, and this month we're providing it to you absolutely FREE! This 115-page document contains a paragraph-by-paragraph English translation of Annex 1 - Annex 5 of the SFDA Guidelines’ original Chinese text. Creating and providing this document is just one of the many ways ISPE is connecting a world of pharmaceutical knowledge. Download your copy now!

FREE Electronic Document: Good Manufacturing Practice (2010 Revision) ( 925 KB)

FREE to Members through 31 October 2011

KNOWLEDGE

With the rapid changes currently underway in the pharmaceutical industry, it’s becoming more common to find companies at all points along the continuum when it comes to commissioning and qualification best practices. ISPE recognized the necessity of having available guidance to answer questions across the entire spectrum, from Baseline to full ICH Q8, Q9, and Q10 adaptation. To that end, we've developed a complete C&Q Guidance Document series that includes the original ISPE Baseline^® Guide (Volume 5): Commissioning and Qualification (which now includes new value-added content to provide information and help facilitate an updated approach to impact assessments), the ISPE Guide: A Science- and Risk-Based Approach to the Delivery of Facilities, Systems, and Equipment, and the soon-to-be-released ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification. Between these three Guides, companies can find answers to virtually any C&Q challenge, no matter where on the best practices spectrum they operate. To help you determine which Guide is right for you, we've developed a FREE Mapping Document that explains the relationship between each of the Guides. Learn how these Guides can help your company develop customized C&Q approaches - read the Mapping Document ( 284 KB) now!

COMMUNITY

ISPE Communities of Practice (COPs) connect like-minded professionals through global networking opportunities and access to a community-specific Body of Knowledge. ISPE is converting its COPs from an online community forum to enhanced COP websites. Four additional COPs have now changed to the new format:

• Critical Utilities (CU) COP
• Operations Management (OM) COP
• Packaging COP
• Process/Product Development (PPD) COP

These COPs join the Active Pharmaceutical Ingredients (API), Biotechnology, Commissioning and Qualification (C&Q), Containment, Disposables, GAMP^®, Investigational Products (IP), Project Management (PM), Good Control Laboratory Practices, Heating, Ventilation and Air Conditioning (HVAC), Process Analytical Technology (PAT), and Sustainable Facilities COPs, which have already been converted.

One of the many benefits of these new COP websites is the ability for COP members to easily access information about the COP and its activities by simply visiting the COP home page. Here, you get the “big picture” first, and all the other ISPE resources related to that COP’s area of expertise are easy to find from there.

To access the COP’s community discussions, simply click on the “Community Discussions” tab on the left side of the COP website. As is currently the process, you must be a COP member and log in to the discussions to begin participating. Note that anyone can read discussions but only ISPE Members can post and respond to questions. For more information about ISPE’s 19 COPs, visit the main COP page on the ISPE website.

PROFESSION

ISPE educational programming, publications and other knowledge resources are planned in response to Member feedback and input. We invite all Subject Matter Experts to fully participate in their development, by participating in our Call for Content process, which is open now.

Here’s how you can submit your ideas for educational content:

• Use this form ( 584 KB) for topics you wish to submit for: Online Learning (webinars, online courses, etc.), Continuing Education, Training, Technical Documents and publications, including Pharmaceutical Engineering magazine, Knowledge Briefs and E-letters.
• Prepare this submission as if it were going to be used to develop a description for marketing and leave blank those sections that do not apply
• Email submissions to Marianne Bock at mbock@ispe.org or Julianne Rill at jrill@ispe.org
• Proposals will be acknowledged when received and will be catalogued for review.

Questions? Call the Continuing Education team at +1-813-960-2105 and dial Marianne Bock at ext. 207 or Julianne Rill at ext. 214.

DID YOU KNOW?

Did you know that as an ISPE Member, you have the benefit of reviewing, commenting on, and influencing the content of Guidance Documents in development?

A critical step in the Document Development process is the industry review and comment period for ISPE Guidance Documents being written by volunteers. As a benefit of membership, you have the exclusive opportunity to influence and improve the content of the document and contribute to important industry guidance.

How does this work? Each Document Development Team is asked to identify specific COPs whose Members possess the right technical knowledge to review and provide feedback on each document under development. Once the COPs are identified, we reach out with a call for reviewers. If you agree to provide feedback by the deadline, we send you a line-numbered PDF of the document with a comment form. We are looking for ISPE Members with expertise in a variety of areas to provide technical comments that will improve the guidance for the benefit of the industry.

Don’t be left out – exercise your right as an ISPE Member and comment on documents in your area of expertise! How do you get involved? Simply identify and join the COPs in your area of expertise; it’s that easy. As a COP Member, you automatically will be notified when we need reviewers.

TELL US WHAT YOU THINK

What did you think of this month's Gift offerings? Are there topics and resources you'd like to see covered in future gift emails? We want to know! Please send all feedback to rjones@ispe.org.